NCT01786135已完成1 期
A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 64
- 试验地点
- 6
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in patients with relapsed or refractory B-lineage non-Hodgkin lymphoma (B-NHL)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma Grade 3, diffuse large B-cell lymphoma (DLBCL), including transformed follicular histology, Burkitt lymphoma, or B-lineage lymphoblastic lymphoma
- •Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy. Patients with DLBCL or follicular lymphoma Grade 3 must have also received intensive salvage therapy.
- •Eastern Cooperative Oncology Group status of 0 or 1
- •Measurable disease
排除标准
- •Allogeneic stem cell transplant (SCT)
研究组 & 干预措施
SGN-CD19A
Experimental
SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)
干预措施: SGN-CD19A (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Through 1 month post last dose
Incidence of laboratory abnormalities
时间窗: Through 1 month post last dose
次要结局
- Duration of response(Until disease progression or start of new anticancer treatment, an expected average of 6 months)
- Blood concentration of SGN-CD19A and metabolites(Through up to approximately 6 weeks post last dose)
- Incidence of antitherapeutic antibodies(Through up to approximately 6 weeks post last dose)
- Objective response according to revised response criteria for malignant lymphoma (Cheson 2007)(Through up to approximately 6 week post last dose)
- Overall survival(Until death or study closure, an expected average of 1 year)
研究者
研究点 (6)
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